Background

Digital health technologies (DHTs) can collect gait and physical activity in adults, but limited studies have validated these in children. This study compared gait and physical activity metrics collected using DHTs to those collected by reference comparators during in-clinic sessions, to collect a normative accelerometry dataset, and to evaluate participants’ comfort and their compliance in wearing the DHTs at-home.

Methods

The MAGIC (Monitoring Activity and Gait in Children) study was an analytical validation study which enrolled 40, generally healthy participants aged 3–17 years. Gait and physical activity were collected using DHTs in a clinical setting and continuously at-home.

Results

Overall good to excellent agreement was observed between gait metrics extracted with a gait algorithm from a lumbar-worn DHT compared to ground truth reference systems. Majority of participants either “agreed” or “strongly agreed” that wrist and lumbar DHTs were comfortable to wear at home, respectively, with 86% (wrist-worn DHT) and 68% (lumbar-worn DHT) wear-time compliance. Significant differences across age groups were observed in multiple gait and activity metrics obtained at home.

Conclusions

Our findings suggest that gait and physical activity data can be collected from DHTs in pediatric populations with high reliability and wear compliance, in-clinic and in home environments.

Trial registration

ClinicalTrials.gov: NCT04823650

Impact

• Digital health technologies (DHTs) have been used to collect gait and physical activity in adult populations, but limited studies have validated these metrics in children.

• The MAGIC study comprehensively validates the performance and feasibility of DHT-measured gait and physical activity in the pediatric population.

• Our findings suggest that reliable gait and physical activity data can be collected from DHTs in pediatric populations, with both high accuracy and wear compliance both in-clinic and in home environments.

• The identified across-age-group differences in gait and activity measurements highlighted their potential clinical value.

中文翻译：

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使用数字健康技术监测儿童活动和步态 (MAGIC)

背景

数字健康技术 (DHT) 可以收集成人的步态和身体活动，但有限的研究在儿童中验证了这些数据。本研究将使用 DHT 收集的步态和身体活动指标与诊所内参考比较器收集的步态和身体活动指标进行比较，以收集规范的加速度测量数据集，并评估参与者在家佩戴 DHT 的舒适度和依从性。

方法

MAGIC（监测儿童活动和步态）研究是一项分析验证研究，招募了 40 名 3-17 岁、总体健康的参与者。在临床环境中和在家中持续使用 DHT 收集步态和身体活动。

结果

与地面真实参考系统相比，使用步态算法从腰部佩戴的 DHT 提取的步态指标之间观察到总体良好到极好的一致性。大多数参与者“同意”或“强烈同意”腕戴式 DHT 和腰戴式 DHT 在家中佩戴都很舒适，佩戴时间合规性分别为 86%（腕戴式 DHT）和 68%（腰戴式 DHT）。在家里获得的多种步态和活动指标中观察到不同年龄组之间存在显着差异。

结论

我们的研究结果表明，可以在诊所和家庭环境中从儿科人群的 DHT 中收集步态和身体活动数据，具有高可靠性和佩戴合规性。

试用注册

ClinicalTrials.gov：NCT04823650

影响

• 数字健康技术 (DHT) 已用于收集成年人的步态和身体活动，但在儿童中验证这些指标的研究有限。

• MAGIC 研究全面验证了 DHT 测量的步态和身体活动在儿科人群中的性能和可行性。

• 我们的研究结果表明，可以从儿科人群的 DHT 中收集可靠的步态和身体活动数据，在诊所和家庭环境中都具有高精度和佩戴合规性。

• 已确定的步态和活动测量的跨年龄组差异凸显了其潜在的临床价值。